[U.S. Food and Drug Administration]

FDA Medical Bulletin * October 1996 * Volume 26 Number 3

REPORTS OF ADVERSE EVENTS
WITH FLUOROQUINOLONES

FDA is asking prescribers and pharmacists to alert patients and other caregivers to the potential for tendinitis and tendon rupture while taking or after taking antimicrobial fluoroquinolones. The Agency has taken steps to have the package insert revised for the following antimicrobial agents: ciprofloxacin, enoxacin, lomefloxacin, norfloxacin, and ofloxacin. Letters have been issued to the manufacturers requesting that they revise their package inserts to include the following information: The WARNINGS section will have a new paragraph that should read: "Ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported with [the specific drug name]. [The specific drug name] should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur at any time during or after therapy with [the specific drug name]."

As an added precaution, the following statement will be added to the Information for Patients subsection of the PRECAUTIONS section: "Patients should be advised to discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise."

The revisions have been made to the ciprofloxacin, enoxacin, and norfloxacin package inserts. The lomefloxacin and ofloxacin revisions should be completed shortly.

REPORT SERIOUS ADVERSE EVENTS AND PRODUCT PROBLEMS TO MEDWATCH
1-800-FDA-1088

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